Wire, Guide, Catheter
FDA product code DQX · 735 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1330
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-12-10 – 2026-09-18
DQX
2004-11-12
DQX
2004-10-15
SILICONE COATED GUIDEWIRE
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DQX
2004-09-16
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
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DQX
2004-08-16
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
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DQX
2004-08-06
FINISHING WIRE SUPPORTRAK
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DQX
2004-08-03
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
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DQX
2004-07-16
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
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DQX
2004-05-17
LAKE REGION HYDROPHILIC GUIDEWIRE
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DQX
2004-04-30
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
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DQX
2004-04-19
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
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DQX
2004-03-03
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
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DQX
2004-03-02
MODIFICATION TO NITREX NITINOL GUIDEWIRE
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DQX
2004-03-01
ARROW ECHOGENIC INTRODUCER NEEDLE
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DQX
2004-02-12
IQ GUIDE WIRE
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DQX
2004-01-12
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
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DQX
2004-01-12
BOSTON SCIENTIFIC V-18 CONTROL WIRE
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DQX
2004-01-07
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
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DQX
2003-12-19
HYDROPHILIC GUIDEWIRE
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DQX
2003-12-11
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
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DQX
2003-12-05
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
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DQX
2003-11-05
SELECTIVA SB GUIDEWIRE
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DQX
2003-10-17
RADIUS COUGAR WIRE
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DQX
2003-10-07
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE
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DQX
2003-09-30
VASCUPUNCTURE PICC GUIDEWIRE
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DQX
2003-09-16
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
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DQX
2003-08-26
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
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DQX
2003-08-13
PBN GUIDEWIRES
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DQX
2003-08-12
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
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DQX
2003-08-08
PERIVAC KIT
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DQX
2003-08-01
IQ HYDROPHILIC GUIDE WIRE
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DQX
2003-07-17
RADIUS 018 COUGAR WIRE
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DQX
2003-07-17
GALT MEDICAL GUIDEWIRE
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DQX
2003-06-24
NITREX NITINOL GUIDEWIRE
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DQX
2003-05-21
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
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DQX
2003-05-14
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
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DQX
2003-05-14
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG
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DQX
2003-02-14
STEERABLE GUIDEWIRE
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DQX
2003-01-24
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
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DQX
2003-01-24
NITREX NITINOL GUIDEWIRE
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DQX
2002-12-16
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
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DQX
2002-12-04
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
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DQX
2002-11-27
ENDOVASCULAR GUIDE WIRE
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DQX
2002-10-28
HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J
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DQX
2002-10-16
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
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DQX
2002-07-26
ILT ADVANCING MECHANISM, MODEL A115AMI
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DQX
2002-07-18
GALT MEDICAL GUIDEWIRE
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DQX
2002-07-11
ILT TORQUER, MODEL 114TR1
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DQX
2002-06-03
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
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DQX
2002-05-22
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
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DQX
2002-05-17
SMARTWIRE/SMARTMAP PRESSURE SYSTEM
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DQX
2002-05-15
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
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DQX
2002-05-02
HI-TORQUE EXTRA S'PORT GUIDEWIRE
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DQX
2002-04-03
SAFE-STEER GUIDE WIRE SYSTEM
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DQX
2002-03-07
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
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DQX
2002-03-01
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
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DQX
2002-02-11
BACK-UP MEIER STEERABLE GUIDEWIRE
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DQX
2002-02-05
VASCUPUNCTURE ACCESS WIRE
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DQX
2002-01-24
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
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DQX
2002-01-16
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096
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DQX
2001-12-13
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
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DQX
2001-12-04
SELECTIVA GUIDEWIRE
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DQX
2001-08-28
SNIPER ELITE MODEL-OR-E3872XX SERIES
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DQX
2001-08-13
BACK-UP MEIER GUIDEWIRE
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DQX
2001-07-25
STREERABLE PTCA GUIDEWIRE
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DQX
2001-05-25
RADIUS COUGAR WIRE
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DQX
2001-05-16
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
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DQX
2001-05-10
MANDREL GUIDEWIRE ASSEMBLY
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DQX
2001-03-22
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
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DQX
2001-03-08
PVS 1300 NEURO GUIDE WIRE
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DQX
2001-03-01
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
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DQX
2001-01-30
APPALEAD GW+03XXXXXXR SERIES
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DQX
2000-12-06
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
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DQX
2000-12-01
WIRECLIP TORQUER
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DQX
2000-11-08
PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING
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DQX
2000-10-04
PRESSURE WIRE SENSOR, MODEL 12003/12303
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DQX
2000-10-04
INQWIRE DIAGNOSTIC GUIDE WIRE
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DQX
2000-09-27
WIRE, GUIDE, CATHETER, MODEL QSW1000
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DQX
2000-08-24
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
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DQX
2000-08-03
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
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DQX
2000-08-02
GALEO HYDRO AND GALEO HYDRO J-TIP
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DQX
2000-07-07
SNIPER, MODEL OR-3872XX SERIES
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DQX
2000-06-07
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
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DQX
2000-05-12
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
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DQX
2000-04-14
AGILITY STEERABLE GUIDEWIRE
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DQX
2000-03-01
MODIFIED HYDROPHILIC COATED GUIDEWIRE
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DQX
2000-02-16
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
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DQX
2000-01-13
ATW MARKER WIRE STEERABLE GUIDEWIRE
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DQX
1999-11-02
BARD HYDROPHILIC COATED GUIDE WIRES
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DQX
1999-10-28
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
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DQX
1999-10-21
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
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DQX
1999-09-23
AGILITY STEERABLE GUIDEWIRE
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DQX
1999-09-09
MEDTRONIC GT2 FUSION GUIDE WIRES
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DQX
1999-08-30
ENDOSONICS TRAK BACK DEVICE
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DQX
1999-07-23
PVS 1400 GUIDEWIRE
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DQX
1999-06-16
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
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DQX
1999-05-05
MODIFICATION TO ULTRA-SELECT GUIDEWIRE
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DQX
1999-04-29
HI-TORQUE BALANCE TREK GUIDE WIRE
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DQX
1999-03-25
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.
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DQX
1999-03-23
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF
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DQX
1999-03-08
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
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